Recall Z-3092-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien, PLC
Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.
| Date | Aug 30, 2011 (initiated Feb 6, 2009) |
| Status | Terminated |
| Reason | Generator may deliver full power when a lower power is selected. |
| Root cause | Component design/selection |
| Action | Covidien sales reps began notifying affected customers on February 6, 2009, followed by a letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the affected product to: Covidien Energy Based Devices 5920 Longbow Road Boulder, Colorado 80301 Customers were asked to label the exterior of the carton with their Return Authorization number. Covidien EbD would address the issue and return the unit to them. For any questions customers were asked to call Covidien EbD's Service Department toll-free at 1-800-255-8522, x 4 |
| Quantity | 357 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Switzerland, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011676 | VIVAWAVE MICROWAVE SYSTEM Vivant Medical, Inc., Jun 18, 2002 |